三重特異性抗體的全球市場:臨床試驗，貿易快速審批的現狀，技術平台與市場機會的展望(2025年)

三特異性抗體市場已成為生物製藥領域一個前景光明且充滿活力的領域，這主要得益於多特異性抗體研究的持續進步。單株抗體和雙特異性抗體的成功為三特異性抗體的開發奠定了基礎，三特異性抗體是免疫療法的下一個創新。這些三特異性抗體針對三種不同的抗原，與單株抗體或雙特異性抗體相比增強了其治療潛力。儘管尚未有三特異性抗體獲得批准，但有幾種候選抗體正處於後期開發階段，一些已進入 II/III 期臨床試驗，這表明在不久的將來有可能獲得批准。

目前，許多公司，無論大小，都專注於三特異性抗體的開發，經常與其他組織合作以共享資源和專業知識。例如，2025 年 1 月，AbbVie 與 Simcere Zaiming 簽署了一份許可選擇權協議，以開發針對 GPRC5D、BCMA 和 CD3 的人源化三特異性抗體 SIM0500。該抗體目前正在美國和中國對復發或難治性多發性骨髓瘤（MM）患者進行 I 期臨床試驗。根據協議，先聲再明將從艾伯維獲得一筆預付款以及潛在的里程碑費用和選擇權費用（取決於專案的成功程度），總額高達 10.55 億美元。

三特異性抗體已顯示出良好的臨床前結果，其效果通常優於傳統療法。一個值得注意的例子是 ISB 2001，由 Ichnos Glenmark Innovation 開發的 BCMA/CD38/CD3 三特異性抗體。在人類細胞系中對楊森的 Tekbairi 和百時美施貴寶的 alnuctamab 候選藥物等雙特異性抗體進行測試時，ISB 2001 殺死癌細胞的有效性提高了 20 到 260 倍。此外，ISB 2001 在消除多發性骨髓瘤患者腫瘤方面已被證明優於 Tekbairi。在動物模型中，低劑量的 ISB 2001 完全消除了所有八隻小鼠的腫瘤，而 Tecvayli 僅抑制了 30.8% 的腫瘤生長。這些令人鼓舞的結果凸顯了三特異性抗體與現有療法相比增強的治療潛力。

三特異性抗體的新臨床試驗不斷湧現，提高了其在癌症治療及其他領域應用的期望。例如，2025年3月，基石藥業宣布其新型PD-1/VEGF/CTLA-4三特異性抗體CS2009的國際多中心I期臨床試驗中首例患者成功給藥。初步報告顯示沒有輸液反應或其他不良事件，進一步證明了這種先進療法的安全性。隨著這些臨床試驗的進展，三特異性抗體的市場預計將擴大，為癌症和其他對常規治療有抗藥性的疾病患者提供新的選擇。

儘管前景樂觀，但三特異性抗體的開發面臨若干挑戰。製造的複雜性和精確針對多種抗原的需要是主要障礙。開發有效且可擴展的製造流程對於三特異性抗體療法的成功至關重要。此外，監管挑戰（特別是在安全性和有效性數據方面）可能會減緩這些創新療法的批准進程。

然而，由於對更有針對性和更有效的癌症治療的需求不斷增加，以及抗體工程和生產技術的進步等因素，三特異性抗體市場持續成長。隨著雙特異性抗體研究的成功數量不斷增加，以及越來越多的臨床試驗證明三特異性抗體的潛力，我們預計會看到對該市場的進一步投資和興趣。因此，三特異性抗體市場預計將在未來幾年經歷顯著成長，更多的研究合作、臨床試驗和潛在的市場批准將為這種有前景的新型治療方法鋪平道路。

本報告提供全球三重特異性抗體市場相關調查，提供市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及加入此市場的主要企業競爭情形等資訊。

目錄

第1章 標靶治療的三重特異性抗體

第2章 三重特異性抗體- 目前臨床開發與未來的商業化的展望

• 目前市場開拓情勢
• 未來市場商業化預測

第3章 各地區的三重特異性抗體臨床及市場開拓趨勢分析

• 美國
• 中國
• EU
• 英國
• 日本
• 澳洲

第4章 三重特異性抗體的治療的臨床傾向，各適應症

• 癌症
  • 乳癌
  • 大腸癌症
  • 肺癌症
  • 腦瘤
  • 多發性骨髓瘤
  • 淋巴瘤
  • 白血病
• 病毒感染
• 眼科疾病
• 自體免疫疾病及發炎性疾病

第5章 企業，國家，適應症，各相的世界三重特異性抗體臨床試驗的洞察

• 研究
• 前臨床
• 第一階段
• 第一/二階段
• 第二/三階段

第6章 全球三重特異性抗體市場動態

• 市場促進因素
• 市場課題

第7章 三重特異性抗體市場最近的趨勢:聯盟，收購，合作，投資

第8章 對成長中的三重特異性抗體的組合方法

• 免疫療法
• 放射治療

第9章 被三重特異性抗體的前導的開發使用了的平台

第10章 競爭情形

• Antibody Studio
• BeiGene
• Beijing Mabworks Biotech
• Biocytogen Pharmaceuticals
• Candid Therapeutics
• Chimagen Biosciences
• Chiome Bioscience
• Chugai Pharmaceutical
• Eluminex Biosciences
• Genor Biopharma
• Harpoon Therapeutics
• Ichnos Glenmark Innovation
• KisoJi Biotechnology
• L and L Biopharma
• Lyvgen Biopharma
• Numab
• OPKO Health
• Sanofi
• Shine-On
• Zymeworks

Global Trispecific Antibodies Clinical Trials, Fast Track Status, Technology Platforms & Market Opportunity Outlook 2025 Report Findings & Highlights:

• First Trispecific Antibody Commercial Approval Expected By 2028
• Currently More Than 50 Trispecific Antibodies Are Under Clinical Trials
• Report Includes Clinical Trials Insight On More Than 50 Trispecific Antibodies By Company, Country, Indication & Phase
• China & USA Dominating Trispecific Antibody Research
• Highest Phase Of Development: Phase II/III
• Insight On Platforms Used For Pioneering Trispecific Antibody By Companies
• Trispecific Antibodies Therapeutic Clinical Tends By Region & Indications
• Insight On 20 Key Companies Developing Trispecific Antibodies

The trispecific antibody market has emerged as a promising and dynamic field in biopharmaceuticals, driven largely by ongoing advancements in multispecific antibody research. The success of monoclonal and bispecific antibodies has laid the foundation for the development of trispecific antibodies, a next-generation innovation in immunotherapy. These trispecific antibodies target three distinct antigens, enhancing their therapeutic potential in comparison to their monoclonal and bispecific counterparts. While none of the trispecific antibodies have yet gained approval, several candidates are in advanced stages of development, with some in Phase II/III clinical trials, indicating a potential for approval in the near future.

Many companies, both large and small, are now focusing their efforts on the development of trispecific antibodies, often collaborating with other organizations to pool resources and expertise. For instance, in January 2025, AbbVie and Simcere Zaiming entered into an option-to-license agreement for the development of SIM0500, a humanized trispecific antibody targeting GPRC5D, BCMA, and CD3. This antibody is currently undergoing Phase I clinical trials in the US and China for patients with relapsed or refractory multiple myeloma (MM). Under the agreement, Simcere Zaiming stands to receive an upfront payment from AbbVie, in addition to milestone payments and option fees that could total up to US$ 1.055 Billion, depending on the success of the program.

Trispecific antibodies have demonstrated promising preclinical results, often outperforming traditional therapies. A notable example is ISB 2001, a BCMA/CD38/CD3 trispecific antibody developed by Ichnos Glenmark Innovation. When tested against bispecific antibodies like Janssen's Tecvayli and Bristol Myers Squibb's candidate alnuctamab in human cell lines, ISB 2001 showed a 20- to 260-fold stronger cancer-killing potency. Furthermore, ISB 2001 proved superior to Tecvayli in its ability to eliminate tumors from multiple myeloma patients. In animal models, ISB 2001 completely eradicated tumors in all eight mice treated with a low dose, whereas Tecvayli showed limited efficacy, with only a 30.8% tumor growth inhibition. These promising results highlight the enhanced therapeutic potential of trispecific antibodies in comparison to existing therapies.

New clinical trials for trispecific antibodies continue to emerge, further solidifying their promise in cancer treatment and beyond. For instance, in March 2025, CStone Pharmaceuticals announced the successful dosing of the first patient in a global multicenter Phase I clinical trial of CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody. Early reports indicate that no infusion reactions or other adverse events were observed, providing further evidence of the safety profile of these advanced therapeutics. As these trials progress, the market for trispecific antibodies will likely expand, offering new options for patients with cancer and other conditions that have proven resistant to conventional therapies.

Despite the optimistic outlook, there are several challenges facing the development of trispecific antibodies. The complexity of manufacturing and the need for precise targeting of multiple antigens are among the key hurdles. The development of effective and scalable manufacturing processes will be crucial to ensuring the success of trispecific antibody therapies. Additionally, regulatory challenges, particularly in terms of safety and efficacy data, may slow the path to approval for these innovative treatments.

Regardless, the market for trispecific antibodies continues to grow due to factors such as the growing demand for more targeted and effective cancer therapies, as well as advancements in antibody engineering and production technologies. The increasing success of bispecific antibodies, combined with the growing number of clinical trials demonstrating the potential of trispecifics, is likely to drive further investment and interest in this market. As a result, the trispecific antibody market is expected to see significant growth in the coming years, with more collaborations, clinical trials, and potentially, market approvals paving the way for this promising new class of therapeutics.

Table of Contents

1. Trispecific Antibody As Targeted Therapy

2. Trispecific Antibody - Current Clinical Development & Future Commercialization Outlook

• 2.1 Current Market Development Scenario
• 2.2 Future Market Commercialization Outlook

3. Trispecific Antibody Clinical & Market Development Trend Analysis By Region

• 3.1 US
• 3.2 China
• 3.3 EU
• 3.4 UK
• 3.5 Japan
• 3.6 Australia

4. Trispecific Antibodies Therapeutic Clinical Tends By Indications

• 4.1 Cancer
  • 4.1.1 Breast Cancer
  • 4.1.2 Colorectal Cancer
  • 4.1.3 Lung Cancer
  • 4.1.4 Brain Cancer
  • 4.1.5 Multiple Myeloma
  • 4.1.6 Lymphoma
  • 4.1.7 Leukemia
• 4.2 Viral Infections
• 4.3 Ophthalmic Diseases
• 4.4 Autoimmune & Inflammatory Diseases

5. Global Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

• 5.1 Research
• 5.2 Preclinical
• 5.3 Phase I
• 5.4 Phase I/II
• 5.5 Phase II/III

6. Global Trispecific Antibody Market Dynamics

• 6.1 Market Drivers
• 6.2 Market Challenges

7. Recent Trends In Trispecific Antibody Market: Partnerships, Acquisitions, Collaboration, & Investments

8. Combinations Approaches For Bourgeoning Trispecific Antibody

• 8.1 Immunotherapy
• 8.2 Radiotherapy

9. Platforms Used For Pioneering Trispecific Antibody

• 9.1 Chugai Pharmaceutical - Dual-Ig Platform
• 9.2 Ichnos Sciences - BEAT Platform
• 9.3 Mab Works - Multispecific Antibody Platform
• 9.4 Molecular Partners - DARPin Platform
• 9.5 Merus - Triclonics Platform
• 9.6 Purple Biotech - Tribody Antibody Platform
• 9.7 Shine-On BioMedical - Trispecific T Cell Engager Antibody
• 9.8 Simcere Zaiming - T-Cell Engager Polyspecific Antibody Technology Platform
• 9.9 Tavotek Biotherapeutics - TavoSelect & TavoPrecise Platforms
• 9.10 Zymeworks - Azymetric

10. Competitive Landscape

• 10.1 Antibody Studio
• 10.2 BeiGene
• 10.3 Beijing Mabworks Biotech
• 10.4 Biocytogen Pharmaceuticals
• 10.5 Candid Therapeutics
• 10.6 Chimagen Biosciences
• 10.7 Chiome Bioscience
• 10.8 Chugai Pharmaceutical
• 10.9 Eluminex Biosciences
• 10.10 Genor Biopharma
• 10.11 Harpoon Therapeutics
• 10.12 Ichnos Glenmark Innovation
• 10.13 KisoJi Biotechnology
• 10.14 L and L Biopharma
• 10.15 Lyvgen Biopharma
• 10.16 Numab
• 10.17 OPKO Health
• 10.18 Sanofi
• 10.19 Shine-On
• 10.20 Zymeworks

List of Figures

• Figure 1-1: Trispecific Antibody As Targeted Therapy
• Figure 2-1: Strategies To Develop Next Generation Trispecific Antibody
• Figure 2-2: Aspects Influencing Future Of Trispecific Antibody
• Figure 3-1: POTENTIA Phase 1 (NCT04839991) Study - Initiation & Completion Year
• Figure 3-2: SAL101JG Phase 1 Study (NCT05735366) - Initiation & Completion Year
• Figure 4-1: NM32-2668 Phase 1 Study (NCT06299163) - Initiation & Completion Year
• Figure 4-2: MK-6070-001/HPN328-4001 Phase 1/2 (NCT04471727) Study - Initiation & Completion Year
• Figure 4-3: MK-6070-002 Phase 1/2 MK-6070-002 (NCT06780137) Study - Initiation & Completion Year
• Figure 4-4: GB263T-FIH001 Phase 1/2 Study (NCT05332574) - Initiation & Completion Year
• Figure 4-5: SIM0500-101 Phase 1 (NCT06375044) Study - Initiation & Completion Year
• Figure 4-6: ISB 2001-101 Phase 1 (NCT05862012) Study - Initiation & Completion Year
• Figure 4-7: CR109234 Phase 1 (NCT05652335) Study - Initiation & Completion Year
• Figure 4-8: JNJ-79635322 Phase 1 (NCT06768489) Study - Initiation & Completion Year
• Figure 4-9: Multiple Myeloma - Trispecific Antibodies With Regulatory Designations
• Figure 4-10: CPIT565A12101 Phase 1 (NCT05397496) Study - Initiation & Completion Year
• Figure 4-11: CR109174 Phase 1 (NCT05424822) Study - Initiation & Completion Year
• Figure 4-12: JNJ-80948543 Phase 2 (NCT06660563) Study - Initiation & Completion Year
• Figure 4-13: JNJ-80948543 Phase 1 (NCT06139406) Study - Initiation & Completion Year
• Figure 4-14: AZD5492 Phase 1/2 (NCT06542250) Study - Initiation & Completion Year
• Figure 4-15: Restoret - Structure
• Figure 4-16: BRUNELLO Phase 2/3 (NCT06571045) Study - Initiation & Completion Year
• Figure 4-17: Ophthalmic Diseases - Eluminex Ophthalmics Trispecific Antibody Candidates
• Figure 4-18: CPIT565B12101 Phase 1 (NCT06335979) Study - Initiation & Completion Year

Figure 6-1 : Trispecific Antibody - Market Drivers

• Figure 6-2: Trispecific Antibody - Market Challenges
• Figure 9-1: Chugai Pharmaceutical - Dual-Ig Platform
• Figure 9-2: Mab Works - Multispecific Antibody Platform
• Figure 9-3: DARPin Platform - Molecular Partners
• Figure 9-4: Merus - Triclonics Platform
• Figure 9-5: Purple Biotech - Tribody Antibody Platform
• Figure 9-6: Shine-On BioMedical - Trispecific T Cell Engager Antibody
• Figure 9-7: Zymeworks Azymetric

List of Tables

• Table 3-1: US - Ongoing Clinical Trials For Trispecific Antibodies
• Table 3-2: EU - Ongoing Clinical Trials For Trispecific Antibodies
• Table 3-3: Australia -Ongoing Clinical Trials For Trispecific Antibodies